Opp - a Universal Mental Health Promoting Mobile Application for Adolescents

NCT05211713 | Active Not Recruiting

• 1 other identifier: 279207
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.

Conditions

Mental Health Wellness 1

Keywords

Mental health promotion; Coping; Adolescents; Mobile application

Outcome Measures

Primary Outcomes (2)

• Change in WHO-5 (WHO-Five Well-being Index)

  WHO-5 (WHO, 1998): A five item self-report questionnaire assessing well-being on a six point scale.

  Change from baseline to six weeks after intervention.

• Change in SDQ (Strengths and Difficulties Questionnaire)

  SDQ (Goodman, 1997): A 25 item self-report assessing mental health and psychosocial functioning in 11-17 years old adolescents on a three point scale.

  Change from baseline to six weeks after intervention.

Secondary Outcomes (4)

• General Self-efficacy scale (GSE)

  Change from baseline to six weeks after intervention.

• Help-seeking behavior

  Change from baseline to six weeks after intervention.

• Self-liking and Competence Scale

  Change from baseline to six weeks after intervention.

• Sleeping quality

  Change from baseline to six weeks after intervention.

Study Arms (2)

Intervention group receiving Opp

EXPERIMENTAL

The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group. Data will be collected at baseline (T1, pre intervention) and after about six weeks of intervention (T2, post intervention).

Device: Opp

Control group

NO INTERVENTION

The waiting list control group will receive the intervention after study completion.

Interventions

Opp DEVICE

Opp is a universal mental health promoting mobile application for adolescents aged 13-25 years.

Intervention group receiving Opp

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents under 16 years whose guardians have given consent

You may not qualify if:

• severe developmental or cognitive challenges

Sponsors & Collaborators

• University of Tromso: lead
• The Dam Foundation: collaborator
• Norwegian Council for Mental Health: collaborator
• Norwegian Directorate of Health: collaborator

Study Sites (1)

UiT The Arctic University of Norway

Tromsø, Norway

Location

Related Publications (1)

• Kaiser S, Rye M, Jakobsen R, Martinussen M, Hogsdal H, Kyrrestad H. A Universal Mental Health-Promoting Mobile App for Adolescents: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 11;12:e42119. doi: 10.2196/42119.

  PMID: 36630167 DERIVED

Related Links

• Homepage

Study Officials

• Henriette Kyrrestad, PhD

  UiT The Arctic University of Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention and control group

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 27, 2022
• Study Start: August 1, 2022
• Primary Completion: November 15, 2023
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)